ISO 13485

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BS EN ISO 13485:2016/A11:2021
BS EN ISO 13485:2016/A11:2021

Medical devices – Quality management systems – Requirements for regulatory purposes The release of the 2021 Amendment of ISO 13485:2016 has created a lot of curiosity amongst medical device organizations and quality professionals.  The question which most of us have is: “What is new in the 2021 amendment of ISO 13485 standard?” Do not worry!…

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ISO 20417:2021
ISO 20417:2021

Medical devices – What information is to be supplied by the manufacturer? As we are very much aware that the ISO 20417:2021 standard is already in town, Elexes Team has detailed in this article the need for the new labeling standard, ISO 20417:2021, which entails the information to be supplied by the manufacturers for a medical device…

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ISO 13485 Certification
Looking for an ISO 13485 Certification?

Introduction to Quality Management System Quality is the most important criterion to be fulfilled by medical device manufacturers to satisfy customers. Medical devices have an impact on the health of the patients, and thus various regulatory bodies across the world also mandate the implementation of the Quality Management System (QMS) for which the most widely…

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ISO 10993-12:2021
ISO 10993-12:2021

Biological evaluation of medical devices – Part 12: Sample preparation and reference materials We all are aware that the 2021 version of the ISO 10993-12 has been released and there is anxiety amongst the medical device professionals and manufacturers regarding the new additions in the amendment. Since this standard has repealed the 2012 version of…

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iso-13485
The Harmonized ISO 13485 – A Brief Insight!

Can you imagine using life-saving medical devices that have not been certified for quality, safety and efficacy? These aspects if compromised, can result in enormous adverse effects and are simply non-negotiable! Let’s take a look at how one can prove their devices to be safe and effective and ensure high quality throughout its life.  ISO…

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qs
Quality Sytems: Facilitating continuous improvement!

What is continuous improvement and how can we achieve it? An answer to this is a premeditated and well-implemented quality management system (QMS). A QMS, in simple words, is a system in which documents on various processes, relevant to the medical device or activities around it, are maintained. This does not mean that QMS is…

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doc
Document Control System: The Core of Quality Management System

Has managing documents always been a tedious and time consuming task for you? Have you faced issues of cost drain and compliance while maintaining the documents for medical devices?  We understand! read below to learn about some document control systems that can help make almost any business more efficient. Due to the very nature of…

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software-as-medical-device
Software as Medical Device (SaMD)

The software has become an integral part of almost all facets of life. It has pronounced usage in the healthcare and medical field. There are three types of software related to medical devices. SaMD is software which on its own is a device employed for a medical purpose. The International Medical Device Regulators Forum (IMDRF)…

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